Senior Documentation Responsible

05/03/20

Location

NULL NULL, , Abroad

Function type

Technical consultancy

Vacancy

CONSULTYS BENELUX is looking for a Senior Documentation Responsible to reinforce its Consulting team. As a consultant you will bring your expertise to our customer team. For this particular project, the main objectives are:
 
  • Create robust GMP documentation and associated training to guarantee its use on the Shopfloor (in place / in use) to guarantee an increase in people's skills (Scientific / Technical skills / GMP and leadership)
  • Bring the documentation of Existing GMP (procedures, operating methods, etc.) at the level of industry standards and in accordance with the expectations of the authorities (US, EU, China)
  • The people in charge will have to interact with the different departments of the site (MSAT, Production, Logistics, Engineering, QC, Quality)
  • Sectors considered: Preparation of sterile material / Aseptic filling Lyophilization / Visual inspection / Quality system
  • Be a referent, advisor and facilitator regarding the RPC project Coordinate the priorities of the team of writers (Create, monitor and coordinate the revision / creation of documents according to standards)
  • Benchmark other sites to identify good practices Participate in different global workstreams of digitalization (Hub transformation team)
  • Propose and set up a new documentary process by ensuring the compliance of documentary procedures with the QMS standard
  • Coordinate the implementation of QMS standards on the site Coordinate the documentation / training interface
  • Create and animate training modules following the RPC project in connection with the documentary process
  • Participate in the construction of the project planning and respect the commitment deadlines

Job application